No preemption in defective defibrillator lawsuit

By Dietrich Knauth

A lawsuit over a LifeVest® medical device that allegedly failed to protect against heart attacks as promised was revived by the U.S. Court of Appeals for the Eleventh Circuit, which found that a lower court had improperly dismissed claims as preempted by an FDA determination that the medical device was safe. In reversing, the appellate panel found that the claims made it through the "narrow" path between express and implied preemption under the Medical Devices Amendments of 1976 (MDA) (Godelia v. Zoll Services, Inc., February 8, 2018, Martin, B.).

A patient suffered a fatal cardiac arrest while wearing a LifeVest, and her estate sued the device manufacturer—Zoll Services, LLC—alleging strict products liability, negligence, fraudulent misrepresentation, fraudulent marketing and promotion, breach of express warranty, negligent misrepresentation, and negligent infliction of emotional distress. The LifeVest is an external defibrillator designed to be worn by patients at risk of sudden cardiac arrest, and is intended to prevent heart attacks by administering a treatment shock when it detects dangerous heartbeat patterns. The U.S. Food and Drug Administration approved LifeVest for sale in 2001, and classified it as a Class III medical device, which is the highest risk category.

The district court previously granted Zoll’s motion to dismiss the suit, finding that the claims were expressly preempted by federal law governing medical devices, notably the MDA [see Products Liability Law Daily’s January 19, 2017 analysis]. The district court found that the claims were premised on the LifeVest being defective, which was at odds with the FDA’s determination that LifeVest was safe.

Reversal. The Eleventh Circuit, on appeal, reversed that ruling, instead finding that the patient’s claims made it through the "narrow" path between express and implied pre-emption under the MDA. The patient did not challenge the FDA’s finding that the device was safe, avoiding express preemption, and did not base claims only on Zoll’s alleged deviance from the FDA-approved manufacture of its devices, avoiding implied preemption. Instead, the appellate court noted, the patient alleged that the LifeVest’s defect was the result of a deviation from approved practices, as shown by an FDA warning letter sent to Zoll after the patient’s death, and that the deviation resulted in actual harm to the patient. The appeals court noted that the district court’s reasoning relied on a previous district court ruling that was later overturned by the Eleventh Circuit.

The Eleventh Circuit also rejected Zoll’s argument that the patient did not plead sufficient detail in the complaint, finding that the patient pleaded a sufficiently plausible claim, and did not need to pinpoint the precise defect that caused the LifeVest malfunction before proceeding with discovery.